Patient Support Organizations
The organizations listed here offer a variety of services that include support, information, and advice to help your patients learn more about living with prostate cancer.
- Professional oncology social workers offer personalized care, and all services are free of charge. CancerCare provides telephone, online and face-to-face counseling, support groups, education, publications, and financial and co-payment assistance.
- Cancer Support Community™ (CSC)
- Largest professionally led nonprofit network of cancer support worldwide, dedicated to ensuring that all people impacted by cancer are empowered by knowledge, strengthened by action, and sustained by community. CSC achieves its mission through three areas: direct service delivery, research, and advocacy.
- Malecare provides technical assistance, training, and information, with a focus on practical solutions that improve services where resources are scarce. Malecare believes that individuals have the right to make informed decisions about their health and to receive care that meets their needs. They work in partnership with governments, institutions, and healthcare professionals to make this right a reality.
- National Alliance of State Prostate Cancer Coalitions (NASPCC)
- NASPCC is a national non-profit organization whose mission is to develop and mentor state prostate cancer coalitions, and to engage in awareness and education as well as public policy advocacy. As an alliance of participating state prostate cancer coalitions, we serve as a national voice in prostate cancer.
- Prostate Cancer Foundation (PCF)
- The Prostate Cancer Foundation is the world's leading philanthropic organization funding and accelerating prostate cancer research. PCF is committed to saving lives and finding a cure for prostate cancer by funding medical research for innovative treatments, connecting patients, loved ones, care providers, and scientists to new developments and critical updates, and providing hope for men with prostate cancer.
- Prostate Cancer Research Institute (PCRI)
- PCRI's vision is to provide insightful clinical research in combination with high-level educational activities directed at both the patient and physician, to greatly enhance outcomes for patients with prostate cancer everywhere.
- Prostate Conditions Education Council (PCEC)
- As a leading innovative organization, PCEC provides a vast array of services including improving access to treatment options, prostate-specific antigen (PSA) testing, information on genomic markers and personalized medicine, and access to clinical research, as well as education and awareness for all stages of prostate cancer. Our mission is to save, extend, and improve the lives of men and their loved ones who are impacted by prostate cancer.
- Prostate Health Education Network (PHEN)
- PHEN’s mission is to eliminate the African-American prostate cancer disparity. It also aims to include advocacy efforts to increase the overall support and resources to wage a war on prostate cancer that will eventually lead to a cure for the disease for the benefit of all men.
- Us TOO International Prostate Cancer Education & Support Network
- Us TOO serves as a resource of volunteers with peer-to-peer support and educational materials to help men and their families/caregivers make informed decisions about prostate cancer detection, treatment options, and related side effects.
- ZERO—The End of Prostate Cancer
- ZERO leads the fight to end the disease by advancing research, encouraging action, and providing education and support to men and their families.
Astellas and Medivation are not affiliated with and do not endorse any of the listed organizations or resources. The information provided by Astellas and Medivation is for informational purposes only and is not meant to replace a doctor's or nurse's advice.
XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Important Safety Information
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.
Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.
The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.
In the placebo-controlled study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
Infections: In the study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.
Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm.
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.
Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.
Please see Full Prescribing Information for additional safety information.
FORMULARY STATUS DOES NOT IMPLY SAFETY OR EFFICACY.
A product’s placement on a plan formulary involves a variety of factors known only to the applicable plan and is subject to eligibility. Provider communication only—not approved for prescription drug plan member distribution. Formulary status is not a guarantee. Please verify copay, coinsurance, coverage, and updated information with the plan sponsors. Information subject to change without notice. Astellas does not endorse any individual plans.